Baclofen 5 mg 5 mL Oral Solution. PL 06464 （5毫升口服巴氯芬5毫克的解决方案。）.pdf

BACLOFEN 5 MG/5 ML ORAL SOLUTION PL 06464/2354 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of product characteristics Page 12 Patient information leaflet Page 19 Labelling Page 22 MHRA PAR; BACLOFEN 5 MG/5 ML ORAL SOLUTION, PL 06464/2354 1 BACLOFEN 5 MG/5 ML ORAL SOLUTION PL 06464/2354 LAY SUMMARY The Medicines and Healthcare products Regulatory Agency (MHRA) granted a Marketing Authorisation (licence) for the medicinal product Baclofen 5 mg/5 mL Oral Solution (product licence number: 06464/2354). Baclofen 5 mg/5 mL Oral Solution contains the muscle relaxant baclofen. It is used to relieve muscle spasms that may occur during certain illnesses affecting the nervous system, such as multiple sclerosis, or following injuries to the head or spine. Baclofen 5 mg/5 mL Oral Solution raised no clinically significant safety concerns and it was, therefore, judged that the benefits of using this product outweigh the risks; hence a Marketing Authorisation has been granted. MHRA PAR; BACLOFEN 5 MG/5 ML ORAL SOLUTION, PL 06464/2354 2 BACLOFEN 5 MG/5 ML ORAL SOLUTION PL 06464/2354 SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introductio